JP7478189B2 - Substrate with rotatable struts for medical devices - Patents.com - Google Patents

Description

This disclosure generally relates to medical devices.

Various aspects of the present disclosure relate to a medical device that includes a substrate forming a major surface. The major surface defines a plane and includes a plurality of first struts extending along a first direction that are interconnected with a plurality of second struts extending along the major surface along a second direction that is non-parallel to the first plane. A width of the second struts measured along the major surface is greater than a thickness of the second struts measured perpendicular to the major surface such that when the substrate is stretched in the first direction, an intermediate section of the second strut rotates relative to the first strut such that the intermediate section of the second strut bends out of the plane of the major surface prior to stretching.

In some embodiments, the medical device further comprises a plurality of protrusions extending from an intermediate section of the plurality of second struts. When the substrate is stretched along the second direction, the plurality of protrusions rotate with the intermediate section of the plurality of second struts and protrude outward relative to the plurality of first struts.

The plurality of protrusions can optionally include anchors. In various embodiments, the anchors can be actuated to perform one or more of the following: fixation of the anchor into tissue, delivery of a drug to the tissue, stimulation of the tissue, shielding of the tissue, exposure of the tissue, fixation of the tissue together, fixation of the tissue to a medical device, such as a graft or other component of an implantable medical device. In the same or different embodiments, such protrusions can represent protrusions that include microneedles that can be actuated to deliver a therapeutic fluid or collect a sample.

Various aspects of the present disclosure relate to a medical system that includes the medical device described in the paragraph above and a delivery device configured to induce stretching of the substrate. Deployment of the medical device includes stretching the substrate such that the second strut rotates relative to the first strut.

Various aspects of the present disclosure also relate to a medical system including the medical device described in the preceding paragraph and a delivery device configured to deliver the medical device into a narrow opening of a patient. The substrate is a flat sheet that is rolled within the delivery device. The delivery device is operable to deploy the substrate within the narrow opening such that the flat sheet is at least partially unrolled within the narrow opening. The medical device is configured to be used as a hernia patch, with the multiple protrusions configured to contact or penetrate tissue of the patient adjacent a tissue opening in the hernia.

Various aspects of the present disclosure relate to a medical system including the medical device described in the preceding paragraph and a delivery device configured to deliver the medical device in a collapsed state to the medical device within a vessel of a patient. The delivery device is operable to deploy a tubular substrate within the vessel. Deploying the medical device includes stretching the tubular substrate to an expanded state such that the second strut rotates relative to the first strut.

Various aspects of the present disclosure also relate to a method of manufacturing the medical device described in the preceding paragraph. The method includes cutting a sheet of substrate material to form a substrate including a plurality of first struts and a plurality of second struts. The plurality of first struts are interconnected with a plurality of second struts in the cut sheet of substrate material.

The accompanying drawings are included to provide a further understanding of the disclosure, are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description, serve to clarify the principles of the disclosure.

FIG. 1 shows an example substrate forming longitudinal and lateral struts on its major surfaces with barbed protrusions extending from intermediate sections of the lateral struts, according to one embodiment.

FIG. 2A illustrates the rotation of the barbed protrusions of the example substrate of FIG. 1 after stretching the substrate longitudinally from an initial state. FIG. 2B illustrates the rotation of the barbed protrusions of the example substrate of FIG. 1 after stretching the substrate longitudinally from an initial state. FIG. 2C illustrates the rotation of the barbed protrusions of the example substrate of FIG. 1 after stretching the substrate longitudinally from an initial state. FIG. 2D illustrates the rotation of the barbed protrusions of the example substrate of FIG. 1 after stretching the substrate longitudinally from an initial state.

FIG. 3A shows an example substrate forming longitudinal and lateral struts on its major surfaces with barbed protrusions extending from intermediate sections of the lateral struts, according to one embodiment. FIG. 3B shows an example substrate forming longitudinal and lateral struts on its major surfaces, with barbed protrusions extending from intermediate sections of the lateral struts, according to one embodiment.

FIG. 4A shows an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4B illustrates an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4C illustrates an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4D shows an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4E illustrates an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4F illustrates an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4G shows an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4H shows an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4I shows an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4J illustrates an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment. FIG. 4K shows an example of a protrusion configuration suitable for use with a substrate providing a rotatable strut with protrusions, according to an embodiment.

FIG. 5A shows an example substrate forming serpentine longitudinal struts and lateral struts on its major surfaces, with protrusions extending from rotatable intermediate sections of the lateral struts, according to one embodiment. FIG. 5B shows an example substrate forming serpentine longitudinal struts and lateral struts on its major surfaces, with protrusions extending from rotatable intermediate sections of the lateral struts, according to one embodiment.

FIG. 6 shows an example substrate forming longitudinal and lateral struts on its major surfaces, with microneedle protrusions extending from rotatable intermediate sections of the lateral struts, the struts including lumens in fluid communication with the microneedle protrusions, according to one embodiment.

FIG. 7A shows a balloon inflatable vascular drug delivery system including a substrate forming a circumferential major surface and lateral struts with protrusions extending from rotatable intermediate sections of the lateral struts, according to one embodiment. FIG. 7B illustrates a balloon-inflatable vascular drug delivery system including a substrate forming a circumferential tubular major surface and lateral struts with protrusions extending from rotatable intermediate sections of the lateral struts, according to one embodiment.

FIG. 8A illustrates the deployment of a barbed sleeve from a protrusion that is operable to secure two tissue layers together, according to one embodiment. FIG. 8B illustrates the deployment of a barbed sleeve from a protrusion that is operable to secure two tissue layers together, according to one embodiment. FIG. 8C illustrates the deployment of a barbed sleeve from a protrusion that is operable to secure two tissue layers together, according to one embodiment. FIG. 8D illustrates the deployment of a barbed sleeve from a protrusion that is operable to secure two tissue layers together, according to one embodiment.

FIG. 9A illustrates a medical device suitable for intraluminal delivery according to one embodiment, the medical device including a diameter-adjustable tubular substrate having rotatable struts attached to an elongate member. FIG. 9B illustrates a medical device suitable for intraluminal delivery, according to one embodiment, that includes a diameter-adjustable tubular substrate having rotatable struts attached to an elongate member. FIG. 9C illustrates a medical device suitable for intraluminal delivery, according to one embodiment, that includes a diameter-adjustable tubular substrate having rotatable struts attached to an elongate member. FIG. 9D illustrates a medical device suitable for intraluminal delivery, according to one embodiment, that includes a diameter-adjustable tubular substrate having rotatable struts attached to an elongate member.

FIG. 10A illustrates the removal of a thrombus from a patient's vessel using the medical device of FIGS. 9A-9D, according to one embodiment. FIG. 10B illustrates the removal of a thrombus from a patient's vessel using the medical device of FIGS. 9A-9D, according to one embodiment. FIG. 10C illustrates the removal of a thrombus from a patient's vessel using the medical device of FIGS. 9A-9D, according to one embodiment.

Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be appreciated that the accompanying drawings referred to herein are not necessarily to scale and may be exaggerated to illustrate the various aspects of the present disclosure, and in that regard, the drawings should not be considered limiting.

The embodiments presented herein include medical devices that are operable to extend and/or retract elements suitable for a particular purpose. Among other methods, the elements extend and/or retract in response to stresses applied, particularly by stretching and/or retracting the device. The elements can remain extended and/or retracted or retract to an initial position when the force is removed. In various embodiments, the elements are used to treat or deliver a therapeutic agent to a target site within the body. In the same or different embodiments, the elements can provide fixation for the medical device.

1 shows an example substrate 10 forming a major surface 9 including a plurality of lateral struts 12 and a plurality of longitudinal struts 14. The lateral struts 12 extend along a first direction and are interconnected with the longitudinal struts 14. The longitudinal struts extend along the major surface 9 along a second direction that is not parallel to the first direction. In some, but not all, embodiments, the first direction is approximately perpendicular to the second direction. The substrate 10 is configured such that when the substrate 10 is stretched along a longitudinal direction, a direction perpendicular to the first direction, the lateral struts 12 rotate relative to the longitudinal struts 14 and bend out of the plane defined by the major surface 9 prior to stretching. As referred to herein, stretching along a direction means that at least a portion of the stretch is within the dimensions of that direction. That is, the stretch need not be generally perpendicular to that direction.

Rotation of the lateral struts 12 occurs in response to stretching along their length as a result of the width 11 of the lateral struts 12 measured along the major surface 9 being greater than the thickness (not shown in FIG. 1) of the lateral struts 12 measured perpendicular to the major surface 9. The width need only be marginally greater than the thickness, since rotation occurs when the bending resistance across the strut's thickness is less than the bending resistance across the width. However, the design width and thickness must take into account manufacturing tolerances to ensure that all of the lateral struts rotate in response to stretching of the substrate 10. At least the intermediate sections 15 of the lateral struts 12 are configured to rotate relative to the longitudinal struts 14 and bend out of the plane of the major surface 9 as defined prior to stretching when the substrate 10 is subjected to a stretching force. With or after the rotation of the intermediate section 15 of the lateral strut 12, the intermediate section 15 of the lateral strut 12 bends in a plane parallel to the width of the lateral strut 12 along with the extension of the substrate 10, as shown, for example, in FIGS. 2C and 2D. The plane parallel to the width of the lateral strut 12 includes the major surfaces 9 of the lateral strut 12 and is generally parallel to the plane defined by the directions 30, 32 of the planar substrate 10.

In some embodiments, all or substantially all of the lateral struts 12 are configured to rotate relative to the longitudinal struts 14 and bend out of the plane of the major surface 9 when subjected to a stretching force. In embodiments, such as the example substrate 40 of FIGS. 3A-3B, the longitudinal struts 14 or the strut interconnections 13 between the longitudinal struts 14 and the lateral struts 12 bend to allow substantially all portions of the lateral struts 12 to rotate. In other embodiments, the lateral struts 12 are twisted to facilitate rotation of the intermediate sections 15 of the lateral struts. In such embodiments, the strut interconnections 13 can be reinforced to resist bending of the longitudinal struts 14 or the strut interconnections 13 between the longitudinal struts 14 and the lateral struts 12. This reinforcement can include making the longitudinal struts 14 wider (e.g., in the plane of directions 30, 32) relative to the lateral struts 12 as compared to the embodiments of FIGS. 1-3B.

In the embodiment of FIG. 1, the barbed projections 16 extend from the intermediate sections 15 of the lateral struts 12. When the substrate 10 is stretched along the longitudinal direction, the barbed projections 16 rotate with the lateral struts 12 relative to the longitudinal struts 14 and protrude outward relative to the longitudinal struts 14 as shown in FIGS. 2A-2D. The amount of rotation can be controlled by the amount of stretch along the longitudinal direction.

Furthermore, the rotation of the projections 16 can be increased by providing the lateral struts 12 with a set shape, as in the example of the substrate 10. Specifically, each of the lateral struts 12 forms a shape that alternates at an angle to the transverse direction to form a serpentine section with peaks and valleys, and the longitudinal struts 14 interconnect with the lateral struts 12 adjacent the apex of the peaks and valleys. The projection interconnects 17 between the lateral struts 12 and the projections 16 are between the apex of the peaks and valleys. Such a configuration can increase the degree of rotation of the projections 16 when the substrate 10 is stretched along the longitudinal direction, as compared to an embodiment in which the lateral struts 12 do not incorporate peaks and valleys. In the specific embodiment of FIG. 1, the serpentine sections of the lateral struts 12 include V-shaped sections including peaks and valleys. In other embodiments, the serpentine sections of the lateral struts 12 can include U-shaped sections including peaks and valleys or other configurations.

In the embodiment of FIG. 1, the barbed projections 16 extend along the major surface 9 in a direction generally parallel to the longitudinal struts 14. The substrate 10, including the major surface 9, can be generally flat. Thus, the substrate 10 forming all or a portion of the lateral struts 12, longitudinal struts 14, and optionally the barbed projections 16 can be cut from a flat sheet. In another embodiment, the substrate 10, including the major surface 9, can be tubular, and all or a portion of the lateral struts 12, longitudinal struts 14, and optionally the barbed projections 16 can be cut from a tube. In either embodiment, relatively simple manufacturing methods can be utilized to create a medical device operable to provide rotatable lateral struts 12 having projections 16 configured to rotate relative to the longitudinal struts 14 and relative to the original major surface 9 in response to longitudinal stretching of the substrate material.

For embodiments including a substrate 10 cut from a tube as referred to herein, such as a tubular substrate 10a, the cut pattern for forming all or a portion of the lateral struts 12, longitudinal struts 14, and optionally barbed projections 16 can be oriented in any direction about the major surface such that the barbed projections 16 rotate as a result of radial stretching, stretching along the length of the tubular substrate 10a, or a combination thereof, as shown, for example, in Figures 7A and 7B.

The tubular substrate 10a from which the lateral struts 12 and longitudinal struts 14 are formed forms a major tubular surface that defines a longitudinal axis. In such an embodiment, the protrusions 16 extend generally parallel to the longitudinal axis when the tubular substrate 10a is in an unstretched state, and the protrusions 16 can extend radially outward when the tubular substrate 10a is stretched in a longitudinal direction parallel to the longitudinal axis. Some or all of the protrusions 16 can also be oriented to extend inward when the tubular substrate 10a is stretched longitudinally.

An example step of manufacturing a medical device including a substrate 10 can include cutting a sheet of substrate material to form a substrate 10 including longitudinal struts 14 and lateral struts 12 with strut interconnections 13, as well as barbed projections 16 or portions connected to base or intermediate sections 15 of barbed projections 16. As discussed above, the longitudinal struts 14 can be interconnected with the lateral struts 12 in the cut sheet of substrate material according to a cut pattern to provide strut interconnection points 13. Furthermore, the barbed projections 16 extend from the intermediate sections 15 of the lateral struts 12 in the cut sheet of substrate material according to the cut pattern. In various embodiments, the sheet of substrate material can be a tubular sheet of substrate material or a flat sheet of substrate material. In the case of a tubular sheet of substrate material, the lateral struts 12 and/or longitudinal struts 14 can be tubular or generally spiral rings according to the cut pattern.

The method may further include stretching the substrate 10 along a direction perpendicular to the longitudinal direction, i.e., non-parallel to the longitudinal direction, to rotate the lateral struts 12 relative to the longitudinal struts 14 and to rotate the projections 16 relative to the longitudinal struts 14. With or after the rotation of the intermediate sections 15 of the lateral struts 12, the intermediate sections 15 of the lateral struts 12 bend in a plane parallel to the width of the lateral struts 12 with the extension of the substrate 10, e.g., as shown in Figures 2C and 2D. Such stretching may be reversible, in the sense that it results in an elastic deformation of the substrate 10, or may be non-reversible, in the sense that it results in a plastic deformation of the substrate 10.

The material of the substrate 10 may include one or more of a metal such as stainless steel, a plastic, a superelastic metal such as Nitinol, and/or a shape memory material such as Nitinol. In embodiments in which the substrate 10 includes Nitinol or other elastic material, the substrate 10 may be configured to self-expand to elongate the substrate 10, for example to rotate the lateral struts 12 relative to the major surfaces 9 of the longitudinal struts 14 such that the protrusions 16 are biased to protrude relative to the longitudinal struts 14. As another example, the elastic substrate 10 may be configured to self-contract to retract the substrate 10, for example to bias the protrusions 16 to lie flat against the major surfaces 9 of the longitudinal struts 14. Such elongation may be at least primarily due to mechanical energy rather than thermal energy, although in some examples, the Nitinol substrate may be temperature activated.

The barbed projections 16 represent anchors that include a pointed tip with barbs adapted to inhibit retraction of the projections 16 upon deployment into tissue. The barbed projections 16 and other such anchors are operable to penetrate at least one of the patient's tissue and the graft material of an implantable medical device, such as the graft material of a heart valve device as part of a valve-in-valve implantation procedure. In some embodiments, the projections 16 can be deployed by stretching the substrate 10 and retracted by compressing the substrate 10 or removing the stretching force from the substrate 10.

In different configurations, the protrusions 16 configured as anchors are operable to perform one or more of the following: anchor to tissue, drug delivery to tissue (e.g., as discussed in further detail in connection with FIGS. 7A and 7B), stimulate tissue when coupled to a stimulation generator of a medical device, conceal tissue, expose tissue, secure tissue together, and secure tissue to a medical device, such as a graft or other component of an implantable medical device.

2A-2D illustrate the rotation of barbed protrusions 16 of a substrate 10 by stretching the substrate 10 along a longitudinal direction 30, such as in a direction non-perpendicular to the longitudinal direction 30. FIG. 2A is a top view of the substrate 10 in a flat pattern including longitudinal struts 14, lateral struts 12 and barbed protrusions 16 cut into a flat sheet of substrate material. The longitudinal direction 30 and lateral (width) direction 32 are indicated and represent the major surface 9 including the longitudinal struts 14, lateral struts 12 and protrusions 16.

2B is a top view showing application of force 20 along the longitudinal direction 30 to stretch substrate 10 along the longitudinal direction 30. FIG. 2C shows application of additional pressure 20 to further stretch substrate 10 along the longitudinal direction 30. FIG. 2D is a side view of substrate 10 stretched along the longitudinal direction 30 shown in FIG. 2C. As shown in FIG. 2D, stretching substrate 10 along the longitudinal direction 30 results in rotation 22 of lateral struts 12 and protrusions 16 relative to longitudinal struts 14, such that protrusions 16 point in an outward direction 24 relative to the unstretched plane of substrate 10 including lateral struts 12 and protrusions 16. This rotation occurs because the width 11 of lateral struts 12 measured along major surface 9 is greater than the thickness of lateral struts 12 measured perpendicular to major surface 9 along direction 34, biasing lateral struts 12 to bend in thickness direction 34 rather than width direction 32. The intermediate section 15 of the lateral strut 12 bends in a plane parallel to the width of the lateral strut 12 with the extension of the substrate 10 along the longitudinal direction 30.

The rotation is enhanced by the shape of the lateral struts 12 in that each of the lateral struts 12 is non-linear along the major surface 9 such that the intermediate section 15 of the lateral strut 12 is offset from the strut interconnection 13 between the lateral strut 12 and the longitudinal strut 14 to accentuate the rotation of the protrusion 16 due to stretching of the substrate 10 along the longitudinal direction 30.

When the substrate 10 is stretched along the longitudinal direction 30, the intermediate sections 15 of the lateral struts 12 rotate relative to the longitudinal struts 14 and bend out of the plane of the major surface 9. In some embodiments, only a portion of the lateral struts 12 rotate relative to the longitudinal struts 14, while other portions of the lateral struts 12 twist to allow the rotation. In other embodiments, the longitudinal struts 14 can bend to allow most or all of the portions of the lateral struts 12 to rotate relative to the longitudinal struts 14. With or after the rotation of the intermediate sections 15 of the lateral struts 12, the intermediate sections 15 of the lateral struts 12 bend in a plane parallel to the width of the lateral struts 12 with the extension of the substrate 10 along the longitudinal direction 30, as shown, for example, in FIGS. 2C and 2D. The magnitude of the rotation can be controlled by the magnitude of the stretch along the longitudinal direction.

The illustrated substrate 10 represents examples of various substrate features, and although combinations of these features are clearly within the scope of the present invention, the foregoing examples and illustrations thereof are not meant to suggest that the inventive concepts presented herein are limited to one or more of the features shown in Figures 1 and 2A-2D with fewer, additional, or alternative features. For example, in various embodiments, the major surface of substrate 10 can be a tubular major surface rather than a planar major surface 9.

EMBODIMENT 1
3A and 3B show an example of a stainless steel substrate 40 forming longitudinal struts 44 and lateral struts 42 at a major surface 39, with barbed projections 46 extending from intermediate sections 45 of the lateral struts 42. In some embodiments, the substrate 40 may be a stainless steel substrate. The substrate 40 shown is stretched along a longitudinal direction. In an unstretched state (not shown), a width 41 of the lateral struts 42 measured along the major surface 39 is greater than a thickness 43 of the lateral struts 42 measured perpendicular to the major surface 39.

3A and 3B, substantially all portions of the lateral struts 42, including the intermediate sections 45 of the lateral struts 42, are configured to rotate relative to the longitudinal struts 44 and bend out of the plane of the major surface 39 when the substrate 40 is subjected to a stretching force. Upon or after rotation of the intermediate sections 45 of the lateral struts 42, the intermediate sections 45 of the lateral struts 42 bend in a plane parallel to the width of the lateral struts 42 along with the extension of the substrate 40. The plane parallel to the width of the lateral struts 42 includes the major surface 39 of the lateral struts 42.

The substrate 40 is generally similar to the substrate 10, except that when the substrate is stretched, the protrusions 46 tend to be oriented generally perpendicular to the major surfaces 39 of the longitudinal struts 44. The barbed protrusions 46 and other anchors are operable to penetrate the patient's tissue. Similar to the barbed protrusions 16, the barbed protrusions 46 represent anchors suitable for resisting retraction and preventing withdrawal of the protrusions 46 when deployed within the patient's tissue. In some embodiments, the protrusions 16, 46 can be deployed by stretching the substrate 40 and retracted by compressing the substrate 40 or removing the stretching force from the substrate 40. The magnitude of rotation can be controlled by the magnitude of stretch along the longitudinal direction.

As shown in FIG. 3B, each of the projections 46 includes a base portion 47, a tip portion 48 distal to the base portion, and a body portion 49 between the base portion and the tip portion. At least the base portion 47 is integral with the lateral strut 42. One or both of the tip portion 48 and the body portion 49 may also be integral with the lateral strut 42.

The substrates 10, 40 are suitable for use in medical devices in a variety of configurations for any number of applications. In some embodiments, the projections 46 can include a removable distal section, such as a coating, cap, or distal tip. In different embodiments, the removable distal section can include one or more of an erodible portion, an absorbable portion, a breakaway distal portion, an adhesive distal portion, barbs, a breakaway distal tip, a cap or barbed sleeve (as shown in Figures 8A-8C), biological moieties, or other removable distal section. In any of these embodiments, the removable distal section can include a therapeutic compound.

In various embodiments, the tip portion 48 may be in the form of a point, arrowhead, single-sided arrowhead, barbed, textured, rectangular, square, oval, circular, diamond, triangular, elliptical, polygonal, U-shaped, star-shaped, or any other configuration suitable for the application. Various projection configurations suitable for use with tubular or flat substrates 10, 40 are illustrated in Figures 4A-4K.

The protrusion in Figure 4A gives it a triangular shape.

The protrusion in Figure 4B gives a sharp tip with serrated edges.

The protrusion in Figure 4C presents a symmetrical barbed tip, or arrowhead.

The protrusion in Figure 4D provides an asymmetric barbed tip, i.e., a one-sided arrowhead.

The protrusions in FIG. 4E provide an asymmetrically arranged triangular profile for the longitudinal struts.

The protrusion in Figure 4F gives it a pointed tip.

The protrusion in Figure 4G presents a pointed tip with a series of barbs between the pointed tip and the lateral struts.

The protrusions in FIG. 4H include coincident protrusions extending on either side of the lateral struts such that when the substrate is stretched, the protrusions are configured to rotate relative to the longitudinal struts and point to the opposite side relative to the longitudinal struts.

The protrusions in FIG. 4I include protrusions that extend on opposite sides of alternating side struts such that when the substrate is stretched, the protrusions are configured to rotate relative to the longitudinal struts to point to the opposite side relative to the longitudinal struts.

The protrusion in FIG. 4J includes an opening that facilitates connecting or passing something through the protrusion.

The protrusion in FIG. 4K includes a rotating paddle that helps reveal or hide something by rotating the paddle.

EMBODIMENT 2
Figures 5A and 5B show an example substrate 100 forming a major surface 99 including serpentine longitudinal struts 114 and lateral struts 112 with protrusions 116 extending from rotatable intermediate sections 115 of the lateral struts 112. With the exception of the serpentine longitudinal struts 114, the substrate 100 is otherwise similar to the substrates 10, 40, and the serpentine longitudinal struts 114 may be combined with elements and features previously described in connection with the substrates 10, 40 by substituting the serpentine longitudinal struts 114 for the longitudinal struts 14 or 44. Figure 5A shows the serpentine longitudinal struts 114 in an extended state, and Figure 5B shows the serpentine longitudinal struts 114 in a collapsed state.

The longitudinal struts 114 have a curved shape that is operable to compress and expand the longitudinal struts 114 along the longitudinal direction 130 prior to rotation of the lateral struts 112. For example, initial stretching of the substrate 100 along the direction 130 can elongate the longitudinal struts 114 without rotating the lateral struts 112. After the longitudinal struts 114 are stretched or partially stretched, further stretching of the substrate 100 along the direction 130 can rotate the lateral struts 112 and projections 116 as described above.

Substrate 100 is similar to substrates 10 and 40, and substrates 10 and 40 can be combined with elements and features associated with substrate 100 by including serpentine longitudinal struts having any of the features or elements described in connection with substrates 10 and 40.

EMBODIMENT 3
6 illustrates an example substrate 200 forming longitudinal struts 214 and rotatable lateral struts 212 with microneedle protrusions 216 extending from a middle section 215 of the lateral struts 212. The microneedle protrusions 216 are actuatable to deliver a therapeutic agent or collect a fluid sample, and at least some of the lateral struts 212 and longitudinal struts 214 are tubular structures and are in fluid communication with the microneedle protrusions 216.

As shown, the longitudinal struts 214 include lumens 224 and the lateral struts 212 include lumens 222. The lumens 222, 224 are in fluid communication with the central lumen 226 of the microprotrusions 216 and with the fluid reservoir 220 via the manifold 221. In various embodiments, the fluid reservoir 220 can be used to deliver and/or collect fluids via the central lumen 226 of the microneedle protrusions 216. Apart from the lumens 222, 224 and central lumen 226, the substrate 200 is otherwise similar to the substrates 10, 40, and the microneedle protrusions 216 can be combined with the elements and features previously described in connection with the substrates 10, 40.

In some embodiments, the fluid reservoir 220 is disposed adjacent to the proximal end of a medical device including the substrate 200. In other embodiments, the fluid reservoir 220 is disposed adjacent to the proximal end of a delivery device suitable for facilitating delivery of a medical device including the substrate 200. Such a delivery device can be configured to induce stretching of the substrate 200. For example, the delivery device can include an elongated element to stretch the medical device in a longitudinal direction parallel to a major axis of the delivery device. In the same or a different embodiment, the delivery device can include a balloon to radially or longitudinally stretch the substrate 200 in conjunction with or following release of the medical device from the distal end of a tubular delivery element of the medical device. In such balloon deployment embodiments, the substrate 200 can be a tubular substrate.

Substrate 200 is similar to substrates 10, 40, and 100, and substrates 10, 40, and 100 can be combined with elements and features associated with substrate 200 by including microneedle protrusions and lumens having any of the features or elements described in connection with substrates 10, 40, and 100.

EMBODIMENT 4
Figures 7A and 7B illustrate a balloon-based expandable vascular drug delivery system 300. The vascular drug delivery system 300 includes a substrate 310 having rotatable lateral struts 312 with protrusions 316, and an expandable balloon 350, and is suitable for intravascular delivery to a target site within a patient's vasculature. Upon reaching the target site, the vascular drug delivery system 300 facilitates deployment by remote inflation of the balloon 350. Specifically, Figure 7A illustrates the vascular drug delivery system 300 in a deflated state, and Figure 7B illustrates the drug delivery system 300 in an inflated state.

For example, the vascular drug delivery system 300 may further include a therapeutic agent coating 360 including a therapeutic agent covering all or a portion of the substrate 310, rotatable lateral struts 312 having protrusions 316, and/or an inflatable balloon 350. As described above, protrusions extending from the rotatable struts, such as protrusions 316, may represent microneedles configured to include a therapeutic compound and/or deliver a therapeutic fluid.

The vascular drug delivery system 300 is operable to apply a therapeutic agent to the surrounding tissue along its length. For example, the therapeutic agent can be applied directly to at least a majority of the surrounding tissue along its length.

In some embodiments, the vascular drug delivery system 300 can be configured to displace at least a portion of a fluid, such as blood, along a length of a blood vessel, thereby substantially occluding the vessel along that length. In effect, the proximity of surrounding tissue and the displacement of blood can reduce the amount of therapeutic agent required for effective treatment as well as the amount of therapeutic agent that travels away from the treatment site.

The substrate 310 forms a tubular major surface 309 including circumferential struts 314 and rotatable lateral struts 312 with barbed protrusions 316 extending from an intermediate portion 315 of the lateral struts 312. The substrate 310 is configured such that when the substrate 310 is stretched circumferentially by inflation of the balloon 350, the lateral struts 312 rotate relative to the circumferential struts 314 and bend out of the plane of the major surface 309 such that the barbed protrusions 316 rotate relative to the circumferential struts 314. The major surface 309 forms a tubular shape, and the original plane of the tubular major surface 309 is also tubular. Geometrically, bending out of the plane of the major surface 309 represents bending radially inward or outward.

The plane of the tubular major surface is the plane defined when the tubular substrate is cut longitudinally and laid flat in a generally planar manner. In a tubular arrangement, the plane defined by the tangent to the tubular substrate major surface describes the movement of the protrusions radially inward and/or outward out of the local plane.

In the contracted state of FIG. 7A, the protrusions 316 are aligned with the major surfaces 309 of the lateral struts 312 and circumferential struts 314. In the expanded state of FIG. 7B, the lateral struts 312 with the protrusions 316 are rotated to point outward from the major surfaces 309 of the circumferential struts 314 and out of the original plane of the tubular major surfaces 309.

The tubular major surface 309 of the substrate 310, including the circumferential struts 314 and the lateral struts 312, defines a longitudinal axis 330. The protrusions 316 extend generally perpendicular to the longitudinal axis 330 in both the stretched and unstretched states. As shown in FIG. 7B, the protrusions 316 extend radially outward due to rotation of the intermediate sections 315 of the lateral struts 312 when the substrate 310 is radially stretched. The protrusions 316 remain aligned with the tubular substrate 310 when the substrate 310 is not radially stretched, and the protrusions 316 extend radially outward when radial stretching of the substrate induces rotation of the lateral struts 312 relative to the circumferential struts 314.

In a modified embodiment, the tubular substrate can include rotatable circumferential struts that rotate in response to longitudinal stretching of the substrate. In this embodiment, the protrusions can remain flat relative to the substrate when the substrate is stretched longitudinally but not radially, and can extend radially outward when longitudinal stretching of the substrate induces rotation of the circumferential struts relative to the lateral struts.

In various embodiments, the tubular substrate 310 is radially self-expandable. In such embodiments, the tubular substrate 310 can be constrained within an elongated tubular catheter prior to expansion, and the balloon 350 can be optional. Alternatively, after the tubular substrate 310 has expanded to an intermediate diameter, the balloon 350 can be used to further radially expand the tubular substrate 310 to an expanded diameter, for example, to push the barbed projections 316 into the patient's tissue or other material.

For example, the tubular substrate 310 is radially self-expandable from a collapsed diameter to an intermediate diameter in an elongated tubular catheter and radially balloon-expandable from the intermediate diameter to an expanded diameter. In some such embodiments, the intermediate sections 315 of the lateral struts 312 rotate relative to the circumferential struts 314 between the collapsed diameter and the expanded diameter. In some such embodiments, the intermediate sections 315 of the lateral struts 312 do not rotate significantly relative to the circumferential struts 314 between the collapsed diameter and the intermediate diameter during self-expansion, and rotate mostly between the intermediate diameter and the expanded diameter during balloon expansion.

Substrate 310 is similar to substrates 10, 40, 100, 200, and substrates 10, 40, 100, 200 can be combined with elements and features associated with system 300 by modifying or substituting substrate 310 with any of the features or elements described in connection with substrates 10, 40, 100, 200.

In embodiments where the protrusions 316 are microspikes (with or without a central opening) coated with a therapeutic agent, stretching the substrate 310 fractures the therapeutic agent coating to facilitate delivery of the therapeutic agent coating to patient tissue adjacent the therapeutic agent coating. The microspikes can be used to create drug accumulation sites in vessel walls, such as arterial walls. Such techniques can provide a relatively high drug tissue concentration as well as a place for accumulation to remain (simply to prevent drug particles from being washed downstream after balloon treatment). In such embodiments, the microspike protrusions 316 are exposed during balloon inflation to help rupture the internal elastic lamina layer of the vessel. The microspike protrusions 316 can also be pulled back prior to inflation to be protected during delivery to the target site. In some embodiments, the therapeutic agent 360 can contain a combination of slow-dissolving paclitaxel crystals and a solubilized formulation of the therapeutic compound.

In some embodiments, the balloon 350 can be coated with a therapeutic substance 360, and the microspike protrusions 316 can function to radially align the crystals so that they are forced into the internal elastic lamella of the vessel, as opposed to a similar system without the substrate 310, which simply compresses the internal elastic lamella of the vessel upon inflation. The deployed microspike protrusions 316 (FIG. 7B) can separate the therapeutic substance 360 and generate a higher proportion of vertically oriented drug particles, resulting in drug retention in the arterial wall after inflation and deflation. In contrast, a similar system without the substrate 310 would simply press a flat piece of drug (almost planar to the balloon surface and vessel wall) against the wall with little mechanism for drug attachment to the wall after the balloon is deflated and blood flow is restored. Thus, by including a substrate 310 with microspike protrusions in the drug delivery system, the drug delivery efficiency can be improved and the amount of drug delivered to the patient's blood can be reduced.

Generally, since it is preferred that the microspike protrusions 316 retract when the balloon is deflated, the material of the substrate 310 must be sufficiently elastic to collapse when the balloon is deflated. Such materials can include Nitinol or other metals.

In some embodiments, the microspike protrusions 316 can extend from 200 to 1000 micrometers, such as about 500 micrometers. Such a length allows the formulation to penetrate through the medium from the endothelium toward the adventitia (the target area and site of greatest drug retention), thereby allowing delivery of the drug through the fibrous cap over the arterial wall plaque.

In the same or a different embodiment, the vascular drug delivery system 300 can include about 25 to about 50 microspike protrusions 316 for a balloon size of 5 millimeters in diameter and about 40 millimeters in length. These dimensions and numbers of microspike protrusions 316 are merely examples, and other dimensions and numbers of protrusions can be selected for various applications.

In the same or a different embodiment, the microspike protrusions 316 can be deployed when the balloon is inflated to about half the final diameter. Such a configuration can radially align the segments for delivery to a variety of vessel diameters from about half the final diameter to the final diameter.

The balloon 350 can be selected depending on the design requirements of the particular application, including the resistance to deployment provided by the substrate 310 and the therapeutic substance 360, and the desired range of radial forces to be applied to the vessel wall upon deployment to improve delivery of the therapeutic substance 360 without undesirable damage to the vessel wall.

For example, balloon molding can be conventionally performed using known extrusion, blow molding, and other molding techniques. Typically, the three main steps of the process include extruding a tubular preform, molding the balloon, and annealing the balloon. Depending on the balloon material employed, the preform can be axially stretched prior to blow molding.

The balloon can be attached to an elongate member (not shown) to facilitate delivery within the vessel by a variety of bonding techniques known to those skilled in the art. Examples include, but are not limited to, solvent bonding, heat bonding, and heat shrinking or sealing. The choice of bonding method depends on the materials used to prepare the expandable element and the tubular body.

In accordance with the present disclosure, balloons can be formed using any material known to those skilled in the art that has the desired physical properties. Commonly used materials include thermoplastic elastomers and non-elastomeric polymers and thermosets.

In system embodiment 300, a 6 French collapsed diameter allows for a 5 millimeter deployed diameter and a 40 millimeter balloon length, representing a 250 percent balloon expansion. This example can be adjusted for other vessel sizes, including but not limited to diameters 4-8 millimeters, lengths 40-200 millimeters, introducer sheath sizes 6 French, or introducer sheath sizes 7 French for delivery of a 7 or 8 millimeter deployed diameter balloon.

For below-the-knee use, diameters of 2.0 to 4.0 mm, lengths of 40 to 200 mm, and introducer profiles of 4 to 5 French are available.

In any of these embodiments, the therapeutic substance 360 formulation may be somewhat brittle to facilitate separation and detachment from the microspike protrusions 316 and balloon 350 when deployed.

The system 300 facilitates a variety of coating options. As one example, the therapeutic substance 360 can be above the balloon 350 and below the substrate 310. Such an embodiment allows the microspike protrusions 316 to be deployed without intervention from the therapeutic substance 360. Also, in this embodiment, the substrate 310 protects the therapeutic substance 360 during tracking and primary trauma. In a variation of this embodiment, the balloon 350 can be dip coated prior to attaching the substrate 310 to the balloon 350.

In another embodiment, the therapeutic substance 360 can cover the balloon 350 and the substrate 310 as shown in FIG. 7A. In such an embodiment, the deployment allows the Michael spike protrusions 316 to detach the therapeutic substance 360. In a variation of this embodiment, the substrate 310 and the balloon can all be dip coated after mounting the substrate 310 to the balloon 350.

In another embodiment, the therapeutic substance 360 can be coated on all or only a portion of the substrate 310, such as coated on the microspike protrusions 316. Such an embodiment allows the therapeutic substance 360 to penetrate the vessel wall. This embodiment allows a maximum percentage of the therapeutic substance 360 to be delivered to the vessel wall. In a variation of this embodiment, all of the substrate 310 can be dip coated prior to attachment to the balloon 350.

The embodiment in which the balloon 350 is coated with a therapeutic substance 360 and the microneedles of the protrusions 316 function to radially align the crystals that are pushed into the internal elastic lamina layer of the vessel may provide one or more advantages over a similar drug delivery system that does not include the substrate 310. For example, the applied technique may enhance patient safety by reducing the paclitaxel drug content/device, reducing procedure time by not needing to inflate a pre-deflated balloon prior to deployment (primary angioplasty), reducing inflation time, reducing particles delivered distally via the bloodstream and reducing the occurrence of segment drug overdosage, reducing vessel dissection, reducing vessel recoil requiring stenting due to forced vessel concentric contraction during angioplasty, enhancing clinical outcomes by improving the consistency of drug uptake, and improving drug delivery efficiency, reducing the occurrence of segment drug underdosage, and/or reducing vessel dissection and vessel recoil due to forced concentric expansion from the substrate 310. The microspice protrusions 316 may protect the formulation as the introducer valve tracks across the treatment site. This can reduce loss of drug in tortuous arteries prior to expansion and allow for primary angioplasty. These advantages can result in greater therapeutic success, more consistent patient outcomes, and success spread across a larger patient population (i.e., fewer clinical "non-responders") compared to similar drug delivery systems that do not have the substrate 310.

EMBODIMENT 5
Figures 8A-8C illustrate the deployment of a barbed sleeve from a protrusion to secure two tissue layers together. Specifically, Figure 8A illustrates a blood vessel 460 having tissue layers 462, 464 separated from one another. Figure 8A is representative of a vessel incision, where tissue layer 462 is the vessel wall and tissue layer 464 is an intimal flap.

8B illustrates a balloon-based expandable vascular delivery system 400. The vascular delivery system 400 includes a substrate 410 having rotatable lateral struts 412 with protrusions 416, a circumferential strut (not shown in FIG. 8B), and an expandable balloon 450, and is suitable for intravascular delivery to a target site within a patient's vasculature via an elongate member 440. The vascular delivery system 400 may further include a delivery device (not shown). Once at the target site, the vascular drug delivery system 400 facilitates deployment by remote inflation of the balloon 450.

Vascular delivery system 400 and variations thereof are the same or similar to those described with respect to vascular delivery system 300, except for the addition of a cap 420 that covers the distal end of protrusion 416. In some embodiments, cap 420 can represent a coating or removable sheath over protrusion 416.

The protrusions 416 are attached to the balloon 450 in a non-deployed state, and the cap 420 is deployable in a patient's vasculature with the vascular delivery system 400. Once the target treatment site is reached, the balloon 450 can be remotely inflated, and the protrusions 416 rotate into place upon deployment, e.g., as previously described with respect to the delivery system 300. Inflating the balloon 450 embeds the protrusions 416 and the cap 420 into the vessel wall, including the tissue layers 462, 464, as shown in FIG. 8B. In the specific embodiment shown, the cap 420 can represent a barbed sleeve suitable for fastening together the tissue layers 462, 464, e.g., to repair an intimal flap. As shown in the enlarged portion of FIG. 4B, the cap 420 includes a sharpened tip 422 and barbs 426 in the wall of the cap 420. In the same or different embodiment, the cap 420 can include a drug that can be forced into the vessel wall and remain after removal or retraction of the protrusions 416.

FIG. 8C shows the vascular delivery system 400 being withdrawn from the vessel, leaving behind the cap 420. In this particular embodiment, the intimal flap has been repaired as the cap 420 functions to secure tissue layer 464 to tissue layer 462.

The cap 420 can also be used to deliver a therapeutic agent to the vessel wall. The cap 420 can be permanent or bioabsorbable. The cap 420 can be textured or barbed to lock into tissue. For example, the cap 420 itself can include barbs that help secure the sheath in place. The cap 420 can be polymeric or metallic. The cap 420 can include an expandable portion. For example, the tip of the cap 420 can be coated with a hydrogel that expands when it absorbs moisture. This expandable tip can help secure the cap 420 in place.

Substrate 410 is similar to substrates 10, 40, 100, 200, 310, and substrates 10, 40, 100, 200, 310 can be combined with elements and features associated with system 400 by modifying or substituting substrate 410 with any of the features or elements described in connection with substrates 10, 40, 100, 200, 310.

EMBODIMENT 6
Figures 9A-9D illustrate a medical device 500 suitable for intraluminal delivery. The medical device 500 includes a diametrically adjustable tubular substrate 510 forming rotatable lateral struts 512 with raised edges 515 and circumferential struts 514 attached to an elongate member 540. The raised edges 515 are suitable for removing thrombus from a vessel, as will be described in connection with Figures 10A-10C.

The substrate 510 forms a tubular major surface 509 including circumferential struts 514 and rotatable lateral struts 512. The substrate 510 is configured such that when the substrate 510 is stretched circumferentially by inflation of the balloon 550, the lateral struts 512 rotate relative to the circumferential struts 514 and bend out of the plane of the major surface 509, causing the raised edges 515 to extend radially outward.

The medical device 500 can be part of a vascular delivery system suitable for intravascular delivery to a target site within a patient's vasculature via the elongate member 540. The vascular delivery system can further include an inflatable balloon and/or a delivery device (not shown). Such vascular delivery systems and variations thereof are the same or similar to those described with respect to the vascular delivery system 300, except that there are no protrusions from the lateral struts 512. For example, once the target treatment site is reached, the balloon can be remotely inflated and the lateral struts 512 rotate into place upon deployment, e.g., as previously described with respect to the delivery system 300.

Substrate 510 is similar to substrates 10, 40, 100, 200, 310, 410, and substrates 10, 40, 100, 200, 310, 410 can be combined with elements and features associated with medical device 500 by modifying or substituting substrate 510 with any of the features or elements described in connection with substrates 10, 40, 100, 200, 310, 410.

10A-10C illustrate the removal of a thrombus 565 from a patient's vessel 562 using a medical device 500. The thrombus 565 is a vascular obstruction that may substantially impede blood flow through the vessel 562. The medical device 500 can be used to scrape and remove the thrombus 565 as shown. First, the medical device 500 is delivered to the target treatment site, i.e., the location of the thrombus 565 in the vessel 562 (FIG. 10A). Next, the distal end of the medical device 500, including the substrate 510, is pushed into the thrombus 565 (FIG. 10B). The substrate 510 is then expanded, for example, by a balloon (not shown), to rotate the lateral struts 512 and expose the raised edge 515. The exposed raised edge 515 is then used to scrape and remove the thrombus 565, for example, by rotating the substrate 510 and/or moving the substrate longitudinally within the vessel 562 by remote manipulation of the elongated member 540 (FIG. 10C). The raised edge 515 of the lateral struts 512 can act as a scoop to dislodge the thrombus 565 from the wall of the vessel 562. A bag or other filter (not shown) can be used to capture the released and detached thrombus particles downstream within the vessel 562. The same or similar techniques can be used to remove plaque from within the vessel 562.

EMBODIMENT 7
In some embodiments, with reference to FIG. 7B, the tubular substrate 310 is suitable for intravascular delivery to a target site within a patient's vasculature.

The tubular substrate 310 can be deployed by a balloon (not shown) until the protrusions 316 reach and perforate the blood vessel. In this embodiment, the protrusions 316 are configured with texture or barbs that allow them to engage and grab onto tissue, such as those shown in Figures 4B, 4C, 4D, and 4G. When the balloon is deflated, the barbed protrusions 316 pull the blood vessel or host tissue down with them. In this example, the tubular substrate 310 can be left in the blood vessel and act to reduce the diameter of the blood vessel.

Such techniques can be applied to normalize the ostium of the left atrial appendage, restore competency of venous valves, create a landing zone for an abdominal aneurysm stent-graft just below the renal arteries, and/or completely close the vessel (total occlusion). In some such embodiments, the tubular substrate 310 can operate as a "reverse" stent. In some such embodiments, the tubular substrate 310 can be formed from a shape memory alloy that is heat set to a collapsed diameter. In some embodiments, the protrusions 316 can be heat set outward or outwardly together with the rotatable lateral struts 312 during expansion of the tubular substrate 310 from the collapsed diameter to the expanded diameter.

In some such embodiments, the protrusions 316 can be restrained by the delivery catheter device before the tubular substrate 310 is deployed from the distal end of the delivery catheter device.

In the same or a different embodiment, the tubular substrate 310 can be attached to a balloon to facilitate radial expansion of the tubular substrate 310 and/or penetration of the protrusions 316 into the patient's tissue or graft material. Inflation of the balloon forces the barbs into the tissue or graft material. Deflation of the balloon allows the tubular substrate 310 to pull the hole closed.

At the entrance to the left atrial appendage, the sheath is retracted, deploying the protrusions 316, which act as anchors. Inflation of the balloon pushes the barbs into the tissue. Deflation of the balloon draws the stent into the tubular substrate 310, closing the hole. The stent is thus configured to radially fold and pull together the tissue surfaces captured by the multiple protrusions.

This technique is described in connection with occluding the ostium of a patient's left atrial appendage, but can be applied radially to draw other tissues together. For example, the tubular substrate 310 can be deployed to occlude a blood vessel, to occlude a tubular conduit or organ, to facilitate closure of a wall defect, to facilitate closure of a localized wound, to facilitate closure of an intima wound, or to facilitate occlusion or closure of a hole or void within a patient's body.

In the same or different embodiment, the medical device including the tubular substrate 310 can further include a collar configured to substantially cover the central lumen of the tubular substrate 310. Optionally, such a collar can be slid up the tubular substrate 310 to completely close the hole. Tabs on opposite sides of the projections 316 can be used to capture the collar. If desired for further fixation, a septum defect closure device (such as a Gore Helex or Eclipse) can be deployed through the central lumen of the tubular substrate 310.

The tubular substrate 310 can be combined with other techniques for occluding the left atrial appendage of a patient, for example, as described in U.S. Pat. No. 9,186,152, entitled "Left Atrial Appendage Occlusion Device," which is incorporated herein by reference for all purposes.

EMBODIMENT 8
The medical system can include a medical device having a tubular substrate conforming to one of substrates 10, 40, 100, 200, 310, 410, or 510, and a delivery device configured to deliver the medical device in a collapsed state into a vessel of a patient. The delivery device is operable to deploy the tubular substrate within the vessel. Deployment of the medical device includes stretching the tubular substrate to an expanded state such that the lateral struts are configured to rotate relative to the longitudinal struts. The tubular substrate is configured to engage an inner wall of the vessel.

In some such embodiments, deployment of the medical device includes stretching the tubular substrate to an expanded state such that the lateral struts and the protrusions are configured to rotate relative to the longitudinal struts. The protrusions can be configured to penetrate the inner wall of the vessel.

In the same or a different embodiment, the tubular substrate forms at least a portion of a stent. For example, the projections can function as tissue-engaging members of a stent or stent-graft as described in U.S. Pat. No. 9,333,101, entitled "Medical Device Fixation Anchor," which is incorporated herein by reference for all purposes.

In some of these embodiments in which the tubular substrate forms at least a portion of the stent, the medical device may further include a tubular graft layered with the substrate to form the stent graft.

Embodiment 9 (valve embodiment)
The medical system can include a medical device having a tubular substrate conforming to one of substrates 10, 40, 100, 200, 310, 410, or 510, and a delivery device configured to deliver the medical device in a collapsed state into a patient's vasculature. The delivery device is operable to deploy the tubular substrate within the vasculature. Deployment of the medical device includes stretching the tubular substrate to an expanded state such that the lateral struts are configured to rotate relative to the longitudinal struts.

The substrate of the medical device includes protrusions operable to penetrate at least one of the patient's tissue and the graft material of an implantable medical device, such as the graft material of a heart valve device as part of a valve-in-valve implantation procedure.

EMBODIMENT 10
The medical system can include a medical device having a substrate conforming to one of substrates 10, 40, 100, 200, 310, 410, or 510, and a delivery device configured to deliver the medical device into a narrow opening in a patient. The substrate is a flat sheet that is rolled within the delivery device. The delivery device is operable to deploy the substrate within the narrow opening such that the flat sheet is at least partially unrolled within the narrow opening.

Deploying the medical device can include stretching the substrate to an expanded state such that the lateral struts are configured to rotate relative to the longitudinal struts.

In some such embodiments, the medical device is configured to be used as a hernia patch, and the protrusions are configured to contact or penetrate patient tissue following deployment of the substrate from the delivery device. In such embodiments, the protrusions can be configured to contact or penetrate patient tissue adjacent a tissue opening in a hernia. For example, the substrate can function as a hernia patch as described in U.S. Patent Application Publication No. 2012/0065649, entitled "Surgical Mesh," which is incorporated herein by reference for all purposes.

Some representative embodiments of the present disclosure can be characterized according to the following:

Item 1 - A medical device comprising a substrate forming a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending along a first direction interconnected with a plurality of second struts extending along the major surface along a second direction non-parallel to the first direction, the width of the second struts measured along the major surface being greater than the thickness of the second struts measured perpendicular to the major surface such that when the substrate is stretched in the first direction, an intermediate section of the second struts rotates relative to the first struts such that the intermediate section of the second struts bends out of the plane of the major surface.

Item 2 - A medical device as described in item 1, wherein the first direction is perpendicular to the second direction.

Item 3 - A medical device according to item 1 or 2, in which the second struts extend alternately at angles to the transverse direction to form a serpentine portion having peaks and valleys, and the first struts interconnect with the second struts adjacent the apexes of the peaks and valleys.

Item 4 - The medical device described in item 3, wherein the serpentine portion includes a V-shaped portion including peaks and valleys.

Item 5 - The medical device described in item 3, wherein the serpentine portion includes a U-shaped portion including peaks and valleys.

Item 6 - A medical device described in any of items 1 to 5, wherein the plurality of first struts have a curved shape that is operable to allow the first struts to expand along a first direction prior to rotation of an intermediate section of the second struts when the substrate is stretched along a direction perpendicular to the first direction.
Item 7 - The medical device of any of items 1-6, wherein the substrate comprises one or more of metal, plastic, superelastic metal, and shape memory material.

Item 8 - The medical device of any of items 1-7, wherein the substrate comprises nitinol that is operable to self-expand to extend the substrate along a direction perpendicular to the first direction or to self-contract to retract the substrate along a direction perpendicular to the first direction.

Item 9 - A medical device according to any one of items 1 to 8, in which stretching the substrate along a direction perpendicular to the first direction causes plastic deformation of the substrate.

Item 10 - A medical device according to any one of items 1 to 8, in which stretching the substrate along a direction perpendicular to the first direction results in elastic deformation of the substrate.

Item 11 - A medical device according to any one of items 1 to 10, wherein the substrate is flat.

Item 12 - A medical device according to any one of items 1 to 10, wherein the substrate is a tubular substrate.

Item 13 - The medical device described in item 12, wherein the tubular substrate is radially self-expandable.

Item 14 - The medical device described in item 12 or 13, wherein the tubular substrate is radially balloon expandable.

Item 15 - The medical device of item 14, wherein the tubular substrate is radially self-expandable from a collapsed diameter to an intermediate diameter, the tubular substrate is radially balloon-expandable from the intermediate diameter to an expanded diameter, and the intermediate section of the second strut rotates relative to the first strut between the collapsed diameter and the expanded diameter.

Item 16 - The medical device of item 15, wherein the intermediate section of the second strut rotates relative to the first strut between the intermediate diameter and the expanded diameter, and the intermediate section of the second strut does not rotate significantly relative to the first strut between the collapsed diameter and the intermediate diameter.

Item 17 - The medical device of any of items 1-16, further comprising a therapeutic agent coating covering at least a portion of the substrate, wherein rotation of the intermediate section by stretching the substrate along a direction perpendicular to the first direction fractures the therapeutic agent coating to facilitate delivery of the therapeutic agent coating to patient tissue adjacent the therapeutic agent coating.

Item 18 - The medical device according to any one of items 1 to 17, further comprising a plurality of protrusions extending from intermediate sections of the plurality of second struts, the plurality of protrusions rotating together with the intermediate sections of the plurality of second struts and protruding outward relative to the plurality of first struts when the substrate is stretched along a direction perpendicular to the first direction.

Item 19 - The medical device of item 18, further comprising a cap covering a distal end of each of the plurality of protrusions, the cap configured to remain within the patient tissue after insertion and removal of the distal end into the patient tissue.

Item 20 - The medical device of item 18, wherein each of the plurality of protrusions extends into the substrate parallel to the first strut.

Item 21 - A medical device according to any of items 18 to 20, in which the plurality of protrusions extend from both sides of the plurality of second struts such that when the substrate is stretched along a direction perpendicular to the first direction, the plurality of protrusions rotate with the intermediate section of the plurality of second struts to protrude in an opposing direction relative to the plurality of first struts.

Item 22 - A medical device according to any of items 18 to 21, in which a plurality of protrusions form anchors, each anchor including a pointed tip.

Item 23 - The medical device of item 22, wherein the anchor is operable to penetrate at least one of the patient's tissue and the graft material of the implantable medical device.

Item 24 - The medical device of item 22 or 23, wherein the anchors each include a base portion, a tip portion distal to the base portion, and a body portion between the base portion and the tip portion, and the base portion is integral with one of the intermediate sections of the plurality of second struts.

Item 25 - The medical device of item 24, wherein the anchor is operable to penetrate vascular tissue and is operable to prevent withdrawal once the tip portion has penetrated into the tissue.

Item 26 - The medical device according to item 24 or 25, wherein the shape of the tip portion is selected from the group consisting of pointed, arrowhead, single-sided arrowhead, barbed, textured, rectangular, square, oval, circular, diamond, triangular, elliptical, polygonal, U-shaped and star-shaped.

Item 27 - The medical device of any of items 22 to 26, wherein the anchor is operable to perform one or more of the following: fixation into tissue, delivery of a drug to tissue, stimulation of tissue, concealment of tissue, exposure of tissue, joining of tissue to tissue, and fixation of tissue to the medical device.

Item 28 - A medical device according to any of items 22 to 27, wherein the anchors each include a removable distal section.

Item 29 - The medical device of item 28, wherein the removable distal section comprises one or more of a barbed sleeve, an erodible portion, an absorbable portion, a detachable distal portion, an adhesive distal portion, a barbed detachable distal tip, a therapeutic compound, and a biological portion.

Item 30 - The medical device of items 18-21, wherein the plurality of protrusions are microneedles including lumens in fluid communication with a manifold and a fluid container, and the microneedles are operable to deliver a therapeutic fluid or collect a sample via the lumens and the manifold.

Item 31 - The medical device of item 30, wherein at least some of the first and second struts have a tubular configuration having a lumen and in fluid communication with the microneedle and the fluid reservoir.

Item 32 - A medical device according to item 30 or 31, in which the fluid container is disposed adjacent to a proximal end of a delivery device adapted to facilitate delivery of the medical device.

Item 33 - The medical device of item 30 or 31, wherein the fluid container is positioned adjacent to the proximal end of the medical device.

Item 34 - The medical device of any of items 18-33, further comprising a therapeutic agent coating covering the plurality of protrusions, wherein rotation of the plurality of protrusions by stretching the substrate along a direction perpendicular to the first direction breaks the therapeutic agent coating to facilitate delivery of the therapeutic agent coating to patient tissue adjacent the therapeutic agent coating.

Item 35 - The medical device of any of items 18-34, wherein the substrate is a tubular substrate, the tubular substrate defines a lumen having a longitudinal axis, the plurality of protrusions remain concentric with respect to the substrate when the substrate is not radially stretched, and the plurality of protrusions extend radially outward when radial stretching of the substrate induces a rotation of the second strut relative to the first strut.

Item 36 - The medical device of item 35, wherein the plurality of protrusions remain flat against the substrate when the substrate is stretched longitudinally and not radially.

Item 37 - The medical device of any of items 18-34, wherein the substrate is a tubular substrate, the tubular substrate defines a lumen having a longitudinal axis, the plurality of protrusions remain concentric with respect to the substrate when the substrate is not longitudinally stretched, and the plurality of protrusions extend radially outward when longitudinal stretching of the substrate induces a rotation of the second strut relative to the first strut.

Item 38 - The medical device of item 37, wherein the plurality of protrusions remain flat against the substrate when the substrate is stretched radially and not stretched longitudinally.

Item 39 - The medical device of any of items 35-38, wherein the medical device is configured to radially fold and pull together tissue surfaces captured by the multiple protrusions.

Item 40 - The medical device of item 39, further comprising a collar configured to substantially cover the lumen.

Item 41 - The medical device described in items 35 to 40, wherein the tubular substrate is radially self-expandable.

Item 42 - The medical device described in item 41, wherein the tubular substrate is radially balloon expandable.

Item 43 - The medical device of item 42, wherein the tubular substrate is radially self-expandable from a collapsed diameter to an intermediate diameter, the tubular substrate is radially balloon-expandable from the intermediate diameter to an expanded diameter, and the plurality of protrusions rotate with an intermediate section of the plurality of second struts to protrude outwardly relative to the plurality of first struts between the collapsed diameter and the expanded diameter.

Item 44 - The medical device of item 43, wherein the plurality of protrusions rotate with the intermediate sections of the plurality of second struts to protrude outwardly relative to the plurality of first struts between the intermediate diameter and the expanded diameter, and the plurality of protrusions remain flat relative to the substrate as the substrate expands from the collapsed diameter to the intermediate diameter.

Item 45 - A medical device according to any one of items 12-17 and 35-44, wherein the tubular substrate forms at least a portion of a stent.

Item 46 - The medical device of item 45, further comprising a tubular graft layered with the substrate to form a stent graft.

Item 47 - A medical system comprising the medical device of items 1 to 46 and a delivery device configured to induce stretching of the substrate, wherein deployment of the medical device includes stretching the substrate such that the second strut rotates relative to the first strut.

Item 48 - A medical system comprising the medical device according to any one of items 18 to 34 and a delivery device configured to deliver the medical device into a narrow hole of a patient, the substrate being a flat sheet that is rolled up within the delivery device, the delivery device being operable to deploy the substrate within the narrow hole such that the flat sheet is at least partially unrolled within the narrow hole, and the medical device being configured to be used as a hernia patch, with the multiple protrusions configured to contact or penetrate the patient's tissue adjacent a tissue opening in a hernia.

Item 49 - A medical system comprising a medical device according to any one of items 12-17 and 35-46, and a delivery device configured to deliver the medical device in a collapsed state into a patient's vessel, the delivery device being operable to deploy a tubular substrate within the vessel, and deployment of the medical device comprising stretching the tubular substrate to an expanded state such that the second strut rotates relative to the first strut.

Item 50 - The medical system described in Item 49, wherein the raised edges of the tubular substrate are configured to scrape and remove thrombus from within the vessel when the tubular substrate is deployed in an expanded state.

Item 51 - The medical system described in Item 49, wherein the tubular substrate is configured to engage with the inner wall of a blood vessel when deployed in an expanded state.

Item 52 - The medical system of item 49, wherein the medical device is any of the medical devices of items 35-46, and deploying the medical device includes stretching the tubular substrate to an expanded state such that the second strut and the plurality of protrusions rotate relative to the first strut.

Item 53 - The medical system described in Item 52, wherein the multiple protrusions are configured to penetrate the inner wall of the vessel.

Item 54 - A method of manufacturing a medical device according to any one of items 1 to 46, the method including cutting a sheet of substrate material to form a substrate including a plurality of first struts and a plurality of second struts, the plurality of first struts being interconnected with the plurality of second struts in the cut sheet of substrate material.

Item 55 - The method of item 54, wherein the medical device is the medical device of any of items 18-46, and cutting the sheet of substrate material to form the substrate further comprises forming a plurality of protrusions extending from the intermediate section of the second strut.

Item 56 - The method of items 54 or 55, further comprising stretching the substrate along a direction perpendicular to the first direction to rotate the second strut relative to the first strut as the substrate extends along the direction perpendicular to the first direction to bend an intermediate section of the second strut in a plane parallel to the width of the second strut.

The invention of this application has been described above generally and with reference to specific embodiments. It should be understood by those skilled in the art that various modifications and changes can be made to the embodiments without departing from the scope of the present disclosure. Therefore, the embodiments are intended to cover the modifications and changes of the present invention as long as they are within the scope of the appended claims and their equivalents.
(Aspects)
(Aspect 1)
1. A medical device comprising:
a substrate forming a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending along a first direction interconnected with a plurality of second struts extending along a second direction non-parallel to the first direction along the major surface;
a width of the second strut measured along the major surface is greater than a thickness of the second strut measured perpendicular to the major surface such that, when the substrate is stretched in the first direction, an intermediate section of the second strut rotates relative to the first strut such that the intermediate section of the second strut bends out of the plane of the major surface.
Medical equipment.
(Aspect 2)
2. The medical device of claim 1, wherein the first direction is perpendicular to the second direction.
(Aspect 3)
A medical device as described in aspect 1 or 2, wherein the plurality of second struts extend alternately at an angle to the transverse direction to form a serpentine portion having peaks and valleys, and the plurality of first struts interconnect to the plurality of second struts adjacent apexes of the peaks and valleys.
(Aspect 4)
A medical device as described in any of aspects 1-3, wherein the plurality of first struts have a curved shape that is operable to allow the first struts to expand along the first direction prior to rotation of the intermediate section of the second struts when the substrate is stretched along a direction perpendicular to the first direction.
(Aspect 5)
Aspect 5. The medical device of any of aspects 1-4, wherein the substrate is a tubular substrate.
(Aspect 6)
the tubular substrate is radially self-expandable from a collapsed diameter to an intermediate diameter;
the tubular substrate is radially balloon expandable from the intermediate diameter to an expanded diameter;
6. The medical device of aspect 5, wherein the intermediate section of the second strut rotates relative to the first strut between the collapsed diameter and the expanded diameter.
(Aspect 7)
further comprising a plurality of projections extending from the intermediate sections of the plurality of second struts;
the medical device is configured to be radially folded to draw together tissue surfaces captured by the plurality of protrusions.
7. The medical device according to aspect 5 or 6.
(Aspect 8)
Aspect 8. The medical device of any of aspects 5-7, wherein the tubular substrate forms at least a portion of a stent, and the medical device further comprises a tubular graft layered with the substrate to form a stent-graft.
(Aspect 9)
A medical device as described in any of aspects 1-8, further comprising a therapeutic agent coating covering at least a portion of the substrate, wherein rotation of the intermediate section by stretching the substrate along a direction perpendicular to the first direction fractures the therapeutic agent coating to facilitate delivery of the therapeutic agent coating to patient tissue adjacent the therapeutic agent coating.
(Aspect 10)
further comprising a plurality of projections extending from the intermediate sections of the plurality of second struts;
A medical device as described in any of aspects 1-9, wherein when the substrate is stretched along a direction perpendicular to the first direction, the plurality of protrusions rotate with the intermediate sections of the plurality of second struts and protrude outward relative to the plurality of first struts.
(Aspect 11)
A medical device according to any one of aspects 1 to 10;
a delivery device configured to induce stretching of the substrate;
Equipped with
deploying the medical device includes stretching the substrate such that the second strut rotates relative to the first strut.
Healthcare system.
(Aspect 12)
further comprising a plurality of projections extending from the intermediate sections of the plurality of second struts;
the delivery device is configured to deliver the medical device into a narrow aperture of a patient;
the substrate is a flat sheet that is rolled within the delivery device;
the delivery device is operable to deploy the substrate within the narrow aperture such that the flat sheet is at least partially unrolled within the narrow aperture;
the medical device is configured for use as a hernia patch, and the plurality of protrusions are configured to contact or penetrate tissue of the patient adjacent a tissue opening at a hernia.
12. The medical system according to claim 11.
(Aspect 13)
The medical device is the medical device according to any one of aspects 5 to 8,
the delivery device is configured to deliver the medical device in a collapsed state into a vasculature of a patient;
the delivery device is operable to deploy the tubular substrate within the vessel;
deploying the medical device includes stretching the tubular substrate to an expanded state such that the second strut rotates relative to the first strut.
12. The medical system according to claim 11.
(Aspect 14)
14. The medical system of aspect 13, wherein raised edges of the tubular substrate are configured to scrape and dislodge thrombus from within the vessel when the tubular substrate is deployed in the expanded state.
(Aspect 15)
The medical system of claim 13 , wherein the tubular substrate is configured to engage an interior wall of the vessel when the tubular substrate is deployed in the expanded state.

Claims (34)

1. A medical device used to treat or deliver a therapeutic agent to a target site within the body, comprising:
a substrate forming a major surface, said major surface defining a plane, said major surface including a plurality of first struts extending along a first direction along said major surface interconnected with a plurality of second struts extending along a second direction along said major surface, said second struts having an intermediate section having a plurality of projections extending therefrom;
an intermediate section of the second strut and the plurality of protrusions are operable to rotate relative to the first strut when the substrate is stretched in the second direction , or an intermediate section of the second strut and the plurality of protrusions are operable to rotate relative to the first strut and bend out of the plane of the major surface when the substrate is stretched in the first direction;
the plurality of projections include microneedles having lumens operable to be in fluid communication with a manifold and a fluid reservoir;
the fluid container is in fluid communication with the manifold of the second strut .
Medical equipment. The medical device of claim 1, wherein at least some of the first struts and the second struts are tubular structures and have lumens in fluid communication with the microneedles and the fluid reservoir. The medical device of claim 1 or claim 2, wherein the manifold has a therapeutic fluid contained therein. The medical device of claim 1 or claim 2, wherein the fluid container is disposed adjacent to a proximal end of the medical device. The medical device of any one of claims 1 to 4, further comprising a therapeutic agent coating covering the plurality of protrusions, and wherein rotation of the plurality of protrusions by stretching the substrate in the first direction is operable to rupture the therapeutic agent coating. The medical device of any one of claims 1 to 5, wherein the substrate is a tubular substrate, the tubular substrate defining a lumen having a longitudinal axis, the plurality of protrusions remaining concentric with the substrate when the substrate is not radially stretched, and the plurality of protrusions extending radially outward when radial stretching of the substrate induces a rotation of the second strut relative to the first strut. The medical device of claim 6, wherein the plurality of protrusions remain flat against the substrate when the substrate is stretched longitudinally and not radially. The medical device of any one of claims 1 to 5, wherein the substrate is a tubular substrate, the tubular substrate defines a lumen having a longitudinal axis, the plurality of protrusions remain concentric with the substrate when the substrate is not longitudinally stretched, and the plurality of protrusions extend radially outward when longitudinal stretching of the substrate induces a rotation of the second strut relative to the first strut. The medical device of claim 8, wherein the plurality of protrusions remain flat against the substrate when the substrate is stretched radially and not stretched longitudinally. The medical device of any one of claims 6 to 9, wherein the medical device is configured to fold radially to pull together tissue surfaces captured by the plurality of protrusions. The medical device of claim 10, further comprising a collar configured to cover the lumen. The medical device according to any one of claims 6 to 11, wherein the tubular substrate is radially self-expandable. The medical device of claim 12, wherein the tubular substrate is radially balloon expandable. 14. The medical device of claim 13, wherein the tubular substrate is radially self-expandable from a collapsed diameter to an intermediate diameter, the tubular substrate is radially balloon-expandable from the intermediate diameter to an expanded diameter, and the plurality of protrusions rotate with the intermediate section of the plurality of second struts to protrude outwardly relative to the plurality of first struts between the collapsed diameter and the expanded diameter. 15. The medical device of claim 14, wherein the plurality of protrusions rotate with the intermediate section of the plurality of second struts to protrude outwardly relative to the plurality of first struts between the intermediate diameter and the expanded diameter, and the plurality of protrusions remain flat relative to the substrate as the substrate expands from the collapsed diameter to the intermediate diameter. The medical device according to any one of claims 6 to 15, wherein the tubular substrate forms at least a portion of a stent. The medical device of claim 16, further comprising a tubular graft layered with the substrate to form a stent graft. A medical system comprising the medical device of any one of claims 1 to 17 and a delivery device configured to induce stretching of the substrate, wherein deployment of the medical device includes stretching the substrate such that the second strut rotates relative to the first strut. A medical system comprising the medical device according to any one of claims 1 to 5 and a delivery device configured to deliver the medical device into a narrow hole of a patient, the substrate being a flat sheet that is rolled up within the delivery device, the delivery device being operable to deploy the substrate within the narrow hole such that the flat sheet is at least partially unrolled within the narrow hole, and the medical device being configured to be used as a hernia patch, with the plurality of protrusions configured to contact or penetrate tissue of the patient adjacent a tissue opening in a hernia. A medical system comprising the medical device according to any one of claims 6 to 17 and a delivery device configured to deliver the medical device in a collapsed state into a patient's vessel, the delivery device being operable to deploy the tubular substrate within the vessel, and the deployment of the medical device comprising stretching the tubular substrate to an expanded state such that the second strut rotates relative to the first strut. 21. The medical system of claim 20, wherein the raised edges of the tubular substrate are configured to scrape and remove thrombus from within the vessel when the tubular substrate is deployed in the expanded state. 21. The medical system of claim 20, wherein the tubular substrate is configured to engage an inner wall of the vessel when deployed in the expanded state. The medical system of claim 20, wherein the medical device is the medical device of any one of claims 6 to 17, and the deployment of the medical device includes stretching the tubular substrate to the expanded state such that the second strut and the plurality of projections rotate relative to the first strut. The medical system of claim 23, wherein the plurality of protrusions are configured to penetrate an inner wall of the vessel. A method of manufacturing the medical device of any one of claims 1 to 17, the method comprising cutting a sheet of substrate material to form the substrate including the plurality of first struts and the plurality of second struts, the plurality of first struts being interconnected with the plurality of second struts in the cut sheet of substrate material. 26. The method of claim 25, wherein cutting the sheet of substrate material to form the substrate further comprises forming the plurality of protrusions extending from the intermediate section of the second strut. 27. The method of claim 25 or 26, further comprising stretching the substrate in the first direction to rotate the second strut relative to the first strut as the substrate is extended in the first direction to bend the intermediate section of the second strut in a plane parallel to a width of the second strut. 1. A medical device used to treat or deliver a therapeutic agent to a target site within the body, comprising:
a substrate forming a major surface, said major surface defining a plane, said major surface including a plurality of first struts extending along a first direction along said major surface interconnected with a plurality of second struts extending along a second direction along said major surface, said second struts having an intermediate section having a plurality of projections extending therefrom;
an intermediate section of the second strut and the plurality of protrusions are operable to rotate relative to the first strut when the substrate is stretched in the second direction , or an intermediate section of the second strut and the plurality of protrusions are operable to rotate relative to the first strut and bend out of the plane of the major surface when the substrate is stretched in the first direction;
The medical device, wherein the plurality of protrusions comprises a plurality of caps configured to remain within the patient tissue following insertion and removal of the distal end from the patient tissue. 29. The medical device of claim 28, wherein the caps are disposed on the distal tips of the projections. The medical device of claim 28 or claim 29, wherein the plurality of caps include a coating or a removable sheath. The medical device of claim 28 or claim 29, wherein the plurality of caps include a barbed sleeve. The medical device according to any one of claims 28 to 31, wherein the caps are bioabsorbable. The medical device according to any one of claims 28 to 32, wherein the caps are made of a polymer or metal. The medical device according to any one of claims 28 to 33, wherein the caps are coated with a hydrogel that swells when it absorbs moisture.

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